Evaluation of the effect of low level laser on tissue edema, tissue color and pain intensity after crown lengthening surgery in premolars
Design
Split Mouth, double blind, two arm parallel group controlled clinical trial on 12 patients with simple randomization method
Settings and conduct
This study was performed in Birjand Dental School. After crown lengthening surgery, In the intervention areas low level laser irradiation was performed immediately after surgery, one and three days after surgery. There was a gap of at least two weeks between the two surgeries. In the control areas, the device was placed in the mouth but it was turned off and no irradiation was performed. Tissue edema and tissue color were measured one, three and seven days after surgery and pain intensity was measured 24, 48 and 72 hours after surgery. Participants and the examiner were blind. The sealed envelope containing the position of the intervention recipient side was handed directly to the laser irradiator without the examiner's notice. The device used in this study did not produce any signals that alerted the patient to irradiation or no irradiation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The need for crown lengthening surgery on at least two bilateral premolars without gingivitis; 18 to 60 years of age; informed consent.
Exclusion criteria: Systemic diseases affecting wound healing; smoking; long-term use of corticosteroids and antibiotics; pregnancy and lactation; lack of informed consent.
Intervention groups
The intervention in this study was low level laser irradiation that was randomly performed on one side of the jaw. the other side was assigned to the control group. On the intervention side, the laser was irradiated after surgery, and on the control side, no irradiation was performed.
Main outcome variables
Tissue edema, Tissue color, Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054774N1
Registration date:2022-05-25, 1401/03/04
Registration timing:retrospective
Last update:2022-05-25, 1401/03/04
Update count:0
Registration date
2022-05-25, 1401/03/04
Registrant information
Name
Sajjad Abedzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 9719
Email address
g.abedzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2021-08-05, 1400/05/14
Actual recruitment start date
2021-02-23, 1399/12/05
Actual recruitment end date
2022-03-14, 1400/12/23
Trial completion date
2022-03-14, 1400/12/23
Scientific title
The effect of low-level laser on complications after crown lengthening surgery in premolars
Public title
The effect of low-level laser on complications after crown lengthening surgery in premolars
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The need for crown lengthening surgery on at least two premolars without gingivitis on both sides of the jaw
Informed consent
Exclusion criteria:
Suffering from systemic diseases affecting wound healing
Smoking
Long-term use of corticosteroids and antibiotics
Pregnancy and lactation
Lack of informed consent
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral crown lengthening surgery of premolars in each individual
Actual sample size reached:
12
More than 1 sample in each individual
Actual sample size in each individual:
2
Bilateral crown lengthening surgery of premolars in each individual
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with sealed envelope method. Numbers (from 1 to 12) were written for the expected number of patients and placed in a sealed envelope. After drawing, in the first half of the numbers that came out, the intervention area was considered on the right side and in the other half, on the left. Then, based on the time of admission of patients to the study, each patient was assigned a number Sequentially.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and the examiner were considered blind. The paper containing the number assigned to each patient and the position of the intervention recipient side were handed directly to the laser irradiator in sealed envelopes without the examiner's notice. The laser device used in this study did not produce any signals that alerted the patient to irradiation or no irradiation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari Ave.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.BUMS.REC.1399.326
Health conditions studied
1
Description of health condition studied
Crown lengthening surgery of premolars
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of tissue edema
Timepoint
One, three and seven days post-surgery
Method of measurement
Clinical examination checklist
2
Description
Tissue color
Timepoint
One, three and seven days post-surgery
Method of measurement
Clinical examination checklist
3
Description
Pain intensity
Timepoint
24, 48 and 72 hours post-surgery
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this Split-Mouth study, the intervention was low-level laser irradiation. After crown lengthening surgery in each patient, on the intervention side laser was irradiated. The AlGaAS 808nm diode laser was applied to the surgical area in parallel paths from coronal to apical with a power of 0.25 watts, an energy density of 4 joules per square centimeter using continuous irradiation settings.
Category
Treatment - Devices
2
Description
Control group: In each patient, after crown lengthening surgery, on the control side laser device was placed in the mouth to resemble the irradiation for the patient, but in fact the device was turned off and no irradiation was performed. (Placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand dental school
Full name of responsible person
Dr. Narjes Akbari
Street address
Between Pasdaran 1 & 3 alley, Pasdaran Blvd.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1700
Email
dentresearch@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Toba Kazemi
Street address
Ghafari Ave.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Abedzade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 36, Razavi 6 st., Razavi Blvd., Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9177757414
Phone
+98 51 3876 9719
Email
g.abedzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Abedzade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 36, Razavi 6 st., Razavi Blvd., Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9177757414
Phone
+98 51 3876 9719
Email
g.abedzade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Abedzade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 36, Razavi 6 st., Razavi Blvd., Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9177757414
Phone
+98 51 3876 9719
Email
g.abedzade@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main result and patient dental documents can be shared. Informed consent form, clinical study results, study protocol and codes used in the study are fully available.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Changes in primary outcomes cannot be cited in other studies because they are time-dependent. The final results of the study provide a suggestion for more detailed studies with greater scope and longer follow-up.
From where data/document is obtainable
Dr. Marzieh Mohammadi Moghaddam: mohamadi_moghadam@yahoo.com
Sajjad Abedzade: g.abedzade@gmail.com
What processes are involved for a request to access data/document
Sending an email, containing the name of the researcher, the title of the study or the reason for interest, and documents related to the academic researcher, if we see the email, the documents will be sent up to you one month later.